PACTR202005623677468已完成3 期
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial
AIDS Clinical Trials Group0 个研究点目标入组 54 人开始时间: 2020年3月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •Suspected pulmonary tuberculosis plus one or both of the following: a) at least one
- •sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least
- •one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with
- •semi quantitative result of ‘medium’ or ‘high’ and rifamycin resistance not detected.
- •2) Age twelve (12) years or older
- •3) A verifiable address or residence location that is readily accessible for visiting, and
- •willingness to inform the study team of any change of address during the treatment
- •and follow-up period.
- •4) Women of child-bearing potential who are not surgically sterilized must agree to
- •practice a barrier method of contraception or abstain from heterosexual intercourse
- •during study drug treatment.
- •5) Documentation of HIV infection status.
- •6) For HIV-positive individuals, CD4 T cell count greater than or equal to 100
- •cells/mm3 based on testing performed at or within 30 days prior to study entry.
- •HIV-positive individuals will be enrolled in a staged approach as described
- •a. Group 1 (EFV1”): receipt of efavirenz-based antiretroviral therapy
- •(ART) for a minimum of 30 days at the time of enrollment AND a
- •documented HIV viral load less than 200 copies/mL at or within 30 days
- •prior to study entry, OR
- •b. Group 2 (EFV2”): for HIV-positive individuals not on ART at
- •enrollment, planned initiation of efavirenz-based ART before or at study
- •7) Laboratory parameters done at or within 14 days prior to screening:
- •? Serum or plasma alanine aminotransferase (ALT) less than or equal to 3
- •times the upper limit of normal
- •? Serum or plasma total bilirubin less than or equal to 2.5 times the upper
- •limit of normal
- •? Serum or plasma creatinine level less than or equal to 2 times the upper
- •limit of normal
- •? Serum or plasma potassium level greater than or equal to 3.5 meq/L
- •? Hemoglobin level of 7.0 g/dL or greater
- •? Platelet count of 100,000/mm3 or greater
- •8) For all women who are not surgically sterilized or who do not meet the study
- •definition of post-menopausal, a negative pregnancy test at or within seven (7)
- •days prior to screening
- •9) Karnofsky score greater than or equal to 60
- •10)Written informed consent
- •The study will provide study participants with counselling on the importance of contraception.
- •Participants will be provided for with condoms and those who need other forms of barrier
- •contraception will be referred to the appropriate care givers prior to starting study treatment.
排除标准
- •1)Pregnant or breast-feeding
- •2) Unable to take oral medications
- •3) Previously enrolled in this study
- •4) Received any investigational drug in the past 3 months
- •5) More than five (5) days of treatment directed against active tuberculosis within 6
- •months preceding initiation of study drugs
- •6) More than five (5) days of systemic treatment with any one or more of the following
- •drugs within 30 days preceding initiation of study drugs: isoniazid, rifampin,
- •rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin,
- •capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other
- •fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, paraaminosalicylic
- •acid, linezolid, clofazimine, delamanid or bedaquiline
- •7) Known history of prolonged QT syndrome. Site clinicians will assess participants and
- •if there are signs and symptoms of heart disease or suggesting arrhythmias, then the
- •clinician will request for an ECG to rule out prolonged QT syndrome.
- •8) Suspected or documented tuberculosis involving the central nervous system and/or
- •bones and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis
- •9) Current or planned use within six months following enrollment of one or more of the
- •following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry
- •and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than
- •efavirenz, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone,
- •or terfenadine. Individuals who are currently taking efavirenz-based antiretroviral
- •treatment or for whom initiation of efavirenz-based antiretroviral treatment is planned
- •within 17 weeks following enrollment may participate, as per Section 8.3.10.
- •10) Weight less than 40.0 kg
- •11) Known allergy or intolerance to any of the study medications
- •12) Individuals will be excluded from enrollment if, at the time of enrollment, their M.
- •tuberculosis isolate is already known to be re
研究者
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